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Not yet recruiting NCT06595394

Effect of Combined Exercise Training in Patients With Multiple Sclerosis

No phase Interventional Multiple Sclerosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Exercise, Home program.
Who it may be relevant to
Registry conditions: Multiple Sclerosis. Basic parameters: 18 years — 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Investigation of the Effect of Exercise Training in Patient With Sarcopenic Multiple Sclerosis

Overview

The aim of this clinical trial is exercise in sarcopenic MS patients to demonstrate the effectiveness of education. The main questions it aims to answer are: -Can exercise training make a change in muscle thickness in sarcopenic MS patients? --Does exercise training have an effect on balance in sarcopenic MS patients? \- Does exercise training have an effect on the risk of falling in sarcopenic MS patients? Participants will: They will continue combined exercise applications 3 days a week for 8 weeks. Evaluations will be made before the application and at the end of the 8 weeks. The data will be analyzed afterwards.

Detailed description

A significant decrease in physical performance is observed in MS patients. The reasons for this can be changes in muscle contractile structures and symptoms such as sarcopenia. Sarcopenia is a disorder characterized by loss of skeletal muscle mass and decrease in muscle strength and physical performance. Loss of muscle mass seen outside of old age is defined as secondary sarcopenia. In recent years, studies on neurological disorders and their relationship with sarcopenia have increased. Early diagnosis of sarcopenia in neurological patients and implementation of applications aimed at this are important from an early stage. The aim of this study is to examine the effect of exercise training in sarcopenic MS patients. In the study, participants will be applied a combined exercise program 3 days a week for 8 weeks. Parameters such as muscle thickness, balance, and fall risk will be evaluated before and after physiotherapy application including aerobic exercise, balance exercises, and strengthening exercises.

Interventions

  • Other Exercise
    Participants in the experimental group will receive treatment for 8 weeks, 3 sessions per week. Each treatment session will be planned to last 60 minutes. People in the experimental group will receive a combined exercise training consisting of aerobic exercise, balance exercise and strengthening exercises for 8 weeks.
  • Other Home program
    The control group will be followed with a home program for 8 weeks. Patients will be asked to apply the home program, which includes traditional physiotherapy practices, 3 days a week and this will be followed by physiotherapists.

Primary outcome measures

  • Muscle thickness [Time frame: 8 weeks]
Secondary outcome measures (7)
  • SARC -F [Time frame: 8 weeks]
  • Hand grip strength measurement [Time frame: 8 weeks]
  • Bioelectrical impedance analysis [Time frame: 8 weeks]
  • Timed Up and Go (TUG) [Time frame: 8 weeks]
  • Berg Balance Scale (BBS) [Time frame: 8 weeks]
  • Fatigue Severity Scale (FSS) [Time frame: 8 weeks]
  • 6 Minute Walk Test [Time frame: 8 weeks]

Eligibility criteria

Inclusion criteria

  • People diagnosed with MS by a neurologist
  • People with ambulation whose EDSS is 4.5 or below
  • People between the ages of 18-50
  • People who do not exercise regularly and are not included in an exercise program

Exclusion criteria

  • Having been diagnosed with sarcopenia before MS diagnosis
  • Having had an MS attack within the last 30 days
  • Having any musculoskeletal problems that may affect walking and balance
  • Having a diagnosed psychiatric disease that may affect cognitive status
  • Having a neurological disease other than MS

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06595394 · sarcopenicms11

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗